Resources

Polls

: Should patients and care partners be more involved in clinical trial design ?

Yes

No

Unsure

FDA’s mission to expand access to new drugs

Sep 15, 2018

In 2017, the FDA approved 16 new oncology drugs and biologics, including the first two cell-based CAR-T cell therapies. A total of 30 new indications were also approved, along with the first two oncology biosimilars and three next-generation sequencing (NGS) platforms.

FDA Commissioner Dr. Gottlieb said: “This science is bringing forward more novel opportunities to more meaningfully address human disease at a pace that’s faster than ever before. But humankind is still much closer to the beginning than to the end of these endeavors.”

He went on to highlight a number of FDA initiatives intended to modernize the drug regulation process. These include the Oncology Center of Excellence (OCE) which has just marked its first birthday and has been tasked with breaking down “outdated silos” to foster a disease-focused approach.

Dr. Gottlieb also spoke about the FDA’s commitment to widen access to clinical trials and referenced recent calls for more pre-market studies on overall survival endpoints.

“I disagree. And I suspect some of the patients who face long odds, for whom available therapy gives them just a slim chance of long-term survival, might also disagree,” he said.

Building a regulatory system that serves those facing “long odds” depends on breaking down barriers between research and practice, as well as harnessing real-world data.

Astellas Patient Advocacy is a function within Corporate Affairs at Astellas that focuses on creating, building and maintaining third-party relationships. We serve as a conduit between Astellas and external stakeholders to help improve patient outcomes, improve access issues and address patients’ unmet needs head on.